Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2016-P-0159] AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for method, metallic reduction, glucose (urinary, nonquantitative) devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as ”copper reduction tablet test”). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). DATES: This order is effective October 4, 2016. FOR FURTHER INFORMATION CONTACT: Sheila Connors, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4620, Silver Spring, MD 20993-0002, 301-796-6181, Sheila.Connors@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Statutory Background Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) ( 21 U.S.C. 360c ), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification o…